The research into potential corrections of genetic disturbance conditions in the growth of the skull on a cellular level has so far not furnished results useful in practice. Patients suffering from premature cranial suture synostoses (incidence 1:1,000) are therefore dependent on a surgical correction now as before for improvement of their appearance or for a reduction of the risk of functional damage.
The rapid increase of the brain volume throughout the first months in a child's life supports the earliest performance possible of the necessary extensive surgical operation. The age level that is deemed to be most expedient in the sense of risk assessment is stated to be within the range from 4 to 12 months. The necessary operation is extensive and, measured by the age, involves some risks. The comparatively high loss of blood, in particular, lets a simplification and shortening of the duration of the operation appear to be particularly desirable.
From the viewpoint of surgical techniques, the methods of bone fragmentation, re-shaping and repositioning have been commonly adopted, which Paul Tessier had proposed (Tessier P. “Total facial osteotomy”. Crouzon's syndrome, Apert's syndrome: oxycephaly, scaphocephaly, turricephaly. Ann. Chir. Plast. 1967; 12(4): pp. 273 to 286). The surgical technique and the time of operation have been varied by various authors throughout the years then following (Renier D, Lajeunie E, Arnaud E, Marchac D. “Management of craniosynostoses”. Childs Nerv. Syst. 2000; 16(10 to 11): pp. 645 to 658). In this manner, a certain standardization of the conventional techno-methodological approach could be observed in the course of the past 30 years.
As a matter of fact, however, some important and time-consuming aspects of the surgical operation have so far not been the subject matter of trend-setting discussions:    1. The criteria of a precise shape “target” are missing. Without planning criteria, the most important and frequently only indication of the surgical operation—i.e. the most perfect approximation possible to the fictitious “healthy” shape of the skull of the patient—remains left to the operating surgeon's sense of shape or his or her arbitrary aesthetic criteria. The duration of the operation may be prolonged by corrections which are required again and again in the sense of groping for the optimum shape. On account of the individual shape, an objective check of the success is almost precluded.    2. Due to the rigidity of the material, the selection of the shape and the realization in the region of calotte sections presenting different degrees of curvature, for instance in the zone of the forehead, involve a high level of difficulty for the skilled operating surgeon, too.
They are lengthy and wearisome, furnishing sub-optimum results on at least one level rather frequently.
The present invention was accordingly based on the objective to provide target criteria for the treatment of cranial synostoses. A further objective of the invention aims at solving the problems in terms of surgical techniques for re-shaping the skull in the case of congenital or acquired cranial deformations.
A further problem underlying the present invention was the provision of tools for improving and simplifying surgical reconstructions of the skull in the first year of a child's life.